"Female Viagra" In A Little Pink Pill? - Women Had Best Not Bet Their Sex Lives On That PR Claim

Evidently, millions of American women, suffering from low libido (some of them even in their twenties as shown last night and this morning on the news) can't wait to be able to buy what is being marketed as "female Viagra" which is nothing of the sort. Ladies, if you are counting on this pink pill to boost your sex drive you may be sadly disappointed, and before you buy it  (est. $75/month) you need to separate marketing BS from scientific reality.

Viagra, like Cialis,  belongs to a drug class known as PDE5 inhibitors.  Recall the chemical pathways here: the cavernous nerves close to the prostate gland secrete nitric oxide which stimulates release of an enzyme (cyclic GMP) inside the penile smooth muscle cells. This promotes relaxation of smooth muscles and erection. An enzyme known as PDE5 prevents this, since else there may be a prolonged erection. Hence, a PDE5 inhibitor works to suppress secretion of the PDE5 enzyme.

Men use it to get a "boost" before sexual contact, and it generally takes from 1-2 hrs. to work. The experience and effects are entirely "below the belt", i.e. in the genital region. Most males are good for several hours after taking the blue pill because the blood flow assures good connection. Male prostate cancer survivors are also asked to take it - if only to prevent deformation of the penis (say after radical prostatectomy) to enable O2 to get into the tissues.

Indeed, the pre-op use of PDE5 inhibitors is now widely indicated by oncologists for endothelial preconditioning, whereby the endothelium (the lining of the erection spaces) is in some way protected by pre-treatment. Typically, the patient then gets a prescription for a PDE5 inhibitor the day the Foley catheter is removed post-surgery/.  He is then "told to take a full dose of Viagra (100 mg) or Levitra (20 mg) once per week with adequate accompanying stimulation.

These genital mechanics and chemical aspects have not one iota to do with the "little pink pill" called Addyi now on offer to women suffering from low libido. And to believe so is to delude oneself, and hence Addyi is NOT "female Viagra". Moreover, there are more significant side effects while the main one for Viagra may be some indigestion and temporarily blurry vision and higher blood pressure.

The main difference from Viagra is that Addyi works on specific hormones in the woman's brain such as dopamine, serotonin. The increase in libido arrives after the relative strengths of these brain chemicals are "adjusted" by Addyi. There is NO concomitant blood flow to the genital region as there is for males. Also it can take much longer for the effect to kick in. As One Dr. Berman put it this morning on CBS Early Show, "the drug's risks are greater than its benefits" and also:

"It increased the number of sexually satisfying events by less than one event per month".

So, if a woman suffering from hypoactive sexual desire disorder now has sex once a month, Addyi can expect to help her increase that to twice a month. Also,  she can't take it just before a planned encounter like a man can take Viagra. No, she needs to take it "weeks or months" before the effects kick in, according to sex therapist Leonore Tiefler quoted in today's Denver Post.

Meanwhile, she will have to be on guard for the most common side effects, including:

- Dizziness
- Nausea
-Fatigue

And when combined with alcohol, it can cause fainting. Thus the FDA is also requiring a strong warning to women that they should never drink alcohol while taking the drug and stressing the risk that it can cause sudden fainting - a special danger for drivers.

 Fortunately, this pink pill  which goes by the name flibanserin, is only supposed to be issued to specially trained doctors and pharmacists to dispense it. They are also  to keep track of any problems with women taking the drug. Only trained physicians will be allowed to write prescriptions for the pill.              

                     

Alarmist? Hardly. Dr. Susan Wood, a former FDA official now at George Washington University, said she was disappointed by the approval.  She said:

"This is a product that is neither very effective nor particularly. safe. It won't benefit many women and at the same time the approval comes with a lot of restrictions, setting a precedent that a drug for women's sexual health has to be treated in a very special way."

Women desperate for a low libido "cure" would be well advised to take notice. When will this sexual salvation be ready? Sprout Pharmaceuticals' CEO Cindy Whitehead said this morning the planned roll out date is October 17th.

It's Time for Combustion Smokers to Make the Change to E-Cigs!

This is now the 21st century, so just as many other aspects of the culture have changed to reflect new technology, it's time the smoking habit change as well. Enter the new, battery -powered "e-cigs" - which are devices that mimic the sensation of smoking of a real cigarette, without tobacco and without the combustion that fouls the air (and also risks fires in hyper-dry, tinder box areas like SE Colorado. The Black Forest fire may have been started accidentally by a careless smoker tossing his real cig out a car window).

The e-cigs, in contrast to combustion cigs, deliver their nicotine through a smoke like vapor, and when exhaled there is no raunchy, stale tobacco odor to make you gag.  The good news is that e-cigs, according to a new report (CBS) this morning, have been on the market for 10 years and have only recently exploded. In 2011 sales were around $300 million, and in 2012 they doubled to $600 million. This year, according to market analysts, that number will most likely triple to nearly $2 billion.

Of course, this is nothing compared to the $80 b Americans continue to burn on traditional tobacco products, but it's a damned good start. (To show how fearful the major tobacco companies are, they've already initiated their own e-cig brands.)   Most manufacturers, though they're not obliged to list ingredients since e-cigs aren't currently regulated by the FDA, list the main ingredients as: water, nicotine, glycerol,  and propylene glycol- which is responsible for the exhaled smoke.

As for the Health establishment, their take so far is the "jury is still out" in terms of any health risks. Most of them, such as quoted on CBS this morning, are hoping the FDA will soon begin regulation.  Meanwhile, one major manufacturer (of N-JOY) welcomes it and also welcomes the chance to make regular combustion cigs obsolete. According to the CEO, he wants to see his 3 and 6 year olds in a world where they can examine a book of ancient customs and inquire: 'Hey, dad! You actually used to light these things on fire and put 'em in your mouth?'

Actually, I used to do that too. In the 60s, I picked up the habit of smoking two packs of Marlboro 100s each day. I never noticed the foul odor and haze of smoke around me because, well, everyone else was doing it too! (Especially at the Oil Corporation I worked - taking a work break between my junior and senior year of university to earn extra $$) So, no biggie when you pumped the ciggy!  But one day in mid- 1968, I awoke barely able to catch my breath, and rolled off my bed in a coughing fit. It was so frightening it prompted me to kick the habit cold turkey. The only tobacco product I've used since has been the odd cigarillo and that only maybe once or twice a year, if that often. (I haven't smoked one since three years ago).

Meanwhile, my brother John, recently laid to rest, might well have lived longer and had a better quality of life had he not been puffing cigarettes at the rate of 2-3 packs a day. We already know from research how combustion cigarettes basically destroy bodies, starting with the lungs (my cousin Jeff, not long ago died of lung cancer, also from a smoking habit), as well as blood vessels  narrowing them to the point strokes are almost inevitable, if smoking is done long enough and intensely. (I regard anything more than a half pack a day as "intensely").  Kidneys, heart can also be seriously affected, and smokers are also more prone to a host of other health ills, including diabetes, bronchitis, and assorted cancers.

While the jury may be out on e-cigs health-wise, it's a no brainer that they simply can't be as bad as regular cigs. You can't tell me that a battery-operated device that produces some "vapors" is remotely as bad as a burning tobacco "stick" that spews its noxious and toxic fumes all around, affecting everyone in the vicinity with second hand smoke - which we now know is as bad as the first hand crap. So in that sense, at the very least others in a closed surrounding or home won't have to inhale the stuff.

Thankfully, most eating and other establishments in the U.S. (including movies theaters) have foreclosed the option of smoking which gives the rest of us a break. We don't have to smell overpowering tobacco smoke while eating our 'Outback' steak, nor do we have to tolerate a haze of interfering smoke and gag while trying to watch a movie. Having them abolished from airlines is also good, removing that fire risk.

As for me, I've no doubt that with my incipient lung problems and issues I'd long since been dead if I'd continued puffing.

If they are wise, current combustion smokers ought to look at e-cigs at least as a reasonable option, and perhaps even a chance to improve their health instead of adding to woes. If we see the traditional sales plummet as the e-cig sales soar, this will be a good sign.

And maybe, at some future point, no 'cigs' will be needed, e-, or regular!

Politics Must NOT Trump Science!

Over the Bush II years, I had a persistent and serious problem with their primary PR hacks and politicos incessantly interfering with science, and attempting to remake it in their political interests. The most notorious example was in their re-writing and excision of data from an EPA report in 2002 to try to wash out all the evidence for global warming. But there were others, including their noisome efforts in 2004-05 for preventing the over the counter sale of "Plan B" day after contraceptives. In effect, "playing politics with women's health by denying emergency contraception for over the counter sales" in the words of Nancy Northrup, President of the Center for Reproductive Rights which sued the FDA over it in 2005.

Well, the FDA, after many tribulations and false starts, finally appeared to get its act together and approve the Plan B for younger teens without a prescription when Health and Human Services Secretary Kathleen Sebelius stepped in and overruled the FDA - the first time ever in living memory. FDA Commissioner Margaret Hamburg was prepared to remove the current requirement that girls under 17 needed a prescription (and doctor's visit) for the pill, manufactured by Teva Pharmaceutical Industries, Ltd. when the HHS stepped in and blocked it.

This is despite the fact that Teva had submitted two comprehensive studies, one to ascertain if the girls under 17 could understand the labeling, and the other designed to simulate real world use of the product. The findings were, according to Amy Niemann (Teva VP) that 90% of the girls were able to make judicious use of the product.

Having myself worked a short stint (1993- 95) as an FDA documentation adherence specialist (for a radiotherapy software corporation), I know how difficult the threshold is to attain a product that is "safe and effective". I also am aware of the extent of scientific testing that goes into it. This means that if a product is FDA-approved it should be at that threshold or beyond. Yes, the FDA has had lapses, but those need to be examined against the total background of products, varieties of pharmaceuticals it tests, and also bearing in mind how its budget has been pared back under Repug, anti-regulatory rule....especially during the Bush II years.

Ms, Sebelius, for her part, claimed that the label comprehension and actual use study "didn't include data on all ages for which the drug would be approved and over the counter", but this is a bare bollocks cop out and PR feint. It doesn't wash, especially as Hamburg of the FDA noted that its drug review specialists, including pediatricians and obstetricians, "reviewed the totality of the data and agreed ...it should be approved for all females of child-bearing potential".

So how is it that a political appointee purports to know more than these experts with their decades of expertise? In point of fact, she doesn't. This is simply a plain political trumping of science as egregious in its own way as the Bushies trumping of climate science with their own political hackery and reality-revision.

But Obama and his administration ought to be above these games. Further, there is not one damned dot of evidence to prove or show he will gain one more vote from any Catholic or Evangelical by going this route. Indeed, whatever paltry few votes he does gain will likely be offset by votes lost by outraging liberal women's advocacy groups! So why do it? Why not just stand on scientific principle and courage? Why not allow the FDA, as the putative agency overseeing these issues, to have the final say?

Maybe the reason is fear. Fear that it will become a "political football" in 2012. But a real politician, President or party can't control every conceivable issue on every front by political manipulation. Sometimes, you have to master and sustain backbone, and let the chips fall where they may, as opposed to interference. Oh, it also helps if you're splendid on articulating the basis for a decision or an agency decision, without pandering to special (religious) interests in an election year. Make your case the best you can, put it out there, and fuck those who don't accept it. That's their problem! You can't control how everyone thinks or how they take or interpret every last decision by every agency under your purview! Or......how they vote, assuming they do!

At the bottom of it all, NO political party or President ought to be seen to kowtow to a religious group, or religious voters, I don't care how badly those votes are desired. People will see through that anyway and you're no better off. Indeed, the general welfare provision in the Preamble of the Constitution trumps all these political maneuvers since the more kids our teens have out of wedlock, the fewer national resources for all other needs. It's a zero sum game after all, no matter how much the PR mavens try to eradicate that fact.

Ultimately, the best move HHS, Ms. Sebelius and the Obama administration can make now, this very second, is to recall that ill-advised decision to trump the FDA, and to stand forthwith as defenders of science.....devil take the hindmost!